PDMA Requests Prime Minister’s Support to Extend Compliance Deadline for MSMEs on Revised GMP Standards

**PDMA Requests Prime Minister’s Support to Extend Compliance Deadline for MSMEs on Revised GMP Standards**

In a significant development for the Micro, Small, and Medium Enterprises (MSME) sector, the Pharmaceutical Distributors and Manufacturers Association (PDMA) has formally appealed to the Prime Minister to extend the compliance deadline for the revised Good Manufacturing Practices (GMP) standards. The request underscores the challenges faced by MSMEs in the pharmaceutical industry as they strive to align with the updated regulatory framework while grappling with financial and operational constraints.

### The Revised GMP Standards: A Step Toward Quality Assurance

Good Manufacturing Practices (GMP) are a set of guidelines designed to ensure that pharmaceutical products are consistently produced and controlled according to quality standards. These regulations are critical for safeguarding public health, ensuring product efficacy, and maintaining global competitiveness in the pharmaceutical sector.

In recent years, the government has revised GMP standards to align with international benchmarks, such as those set by the World Health Organization (WHO). The updated standards emphasize stricter quality control, enhanced documentation, advanced manufacturing technologies, and improved safety protocols. While these changes are expected to elevate the quality of pharmaceutical products and boost exports, they also pose significant challenges for smaller players in the industry.

### The MSME Dilemma: Struggling to Keep Up

The MSME sector forms the backbone of India’s pharmaceutical industry, contributing significantly to domestic drug production and exports. However, the revised GMP standards have placed a heavy burden on these smaller enterprises, many of which operate on limited budgets and resources. Key challenges faced by MSMEs include:

1. **High Compliance Costs**: Upgrading manufacturing facilities, acquiring new equipment, and implementing advanced quality control systems require substantial financial investment. For MSMEs, these costs can be prohibitive.

2. **Lack of Technical Expertise**: Many smaller firms lack the in-house expertise needed to interpret and implement the revised GMP guidelines effectively.

3. **Disruption to Operations**: Transitioning to the new standards often necessitates temporary shutdowns of manufacturing units, leading to revenue losses.

4. **Limited Access to Credit**: MSMEs frequently face difficulties in securing loans or financial assistance to fund the required upgrades.

Given these challenges, the PDMA has raised concerns that strict adherence to the current compliance deadline could lead to the closure of many MSME units, resulting in job losses and a potential disruption in the supply of affordable medicines.

### PDMA’s Appeal to the Prime Minister

In its appeal to the Prime Minister, the PDMA has requested an extension of the compliance deadline by at least 18 to 24 months. The association has argued that this additional time would allow MSMEs to gradually adapt to the revised standards without jeopardizing their financial stability or operational continuity.

The PDMA has also proposed the following measures to support MSMEs during the transition:

1. **Financial Assistance**: The introduction of government-backed subsidies or low-interest loans to help MSMEs fund the necessary upgrades.

2. **Capacity-B

• Source Link: https://platohealth.ai/pdma-seeks-pms-intervention-to-extend-time-for-msmes-to-comply-with-revised-gmp-standards/